Ibuprofen and Diphenhydramine Citrate

Product NDC: 21130-228
11-digit product format: 211300228
Labeler code: 21130
Product ID: 21130-228_09fc3572-d282-478d-ba22-70690f615e65
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen and Diphenhydramine Citrate
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Better Living Brands, LLC
Application: ANDA216204
Marketing category: ANDA
Marketing start: 2023-11-15
Substance: DIPHENHYDRAMINE CITRATE; IBUPROFEN
Active strength: 38; 200 mg/1; mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET / ORAL			2022-05-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216204-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2022-05-31	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen and Diphenhydramine Citrate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	38 mg/1
DIPHENHYDRAMINE CITRATE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WK2XYI10QM	Internal UNII lookup
4OD433S209	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
895664	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fcfb044d-f6b9-5c43-e053-6394a90ac417	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21130-228-12	Ibuprofen and Diphenhydramine Citrate	1 in 1 CARTON	TABLET, COATED	1	3
21130-228-12	Ibuprofen and Diphenhydramine Citrate	40 in 1 BOTTLE	TABLET, COATED	40	3
21130-228-18	Ibuprofen and Diphenhydramine Citrate	80 in 1 BOTTLE	TABLET, COATED	80	3
21130-228-18	Ibuprofen and Diphenhydramine Citrate	1 in 1 CARTON	TABLET, COATED	1	3
21130-228-23	Ibuprofen and Diphenhydramine Citrate	1 in 1 CARTON	TABLET, COATED	1	3
21130-228-23	Ibuprofen and Diphenhydramine Citrate	120 in 1 BOTTLE	TABLET, COATED	120	3
21130-228-73	Ibuprofen and Diphenhydramine Citrate	1 in 1 CARTON	TABLET, COATED	1	3
21130-228-73	Ibuprofen and Diphenhydramine Citrate	20 in 1 BOTTLE	TABLET, COATED	20	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-228	IBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET, COATED [BETTER LIVING BRANDS, LLC]	3	Current NDC, 8 package rows	20241103_fcfb044d-f6b9-5c43-e053-6394a90ac417.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMAZON BASIC CARE IBUPROFEN PM	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	Amazon.com Services LLC	10ec6386-db13-a9dd-e063-6294a90a8261	2026-03-18	Warnings	Exact identifier application applno (ANDA): 216204 application number: ANDA216204
Ibuprofen and Diphenhydramine Citrate	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	Better Living Brands, LLC	fcfb044d-f6b9-5c43-e053-6394a90ac417	2024-10-29	Warnings	Exact identifier application applno (ANDA): 216204 application number: ANDA216204 ndc (product): 21130-228
Ibuprofen PM	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	KROGER COMPANY	15e649c4-d75f-e8c1-e063-6294a90a7747	2024-07-26	Warnings	Exact identifier application applno (ANDA): 216204 application number: ANDA216204
Ibuprofen and Diphenhydramine Citrate	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	Aurohealth LLC	21c1f5c5-19fa-4a59-bad3-ea85fd37471b	2022-06-03	Warnings	Exact identifier application applno (ANDA): 216204 application number: ANDA216204

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4OD433S209	DIPHENHYDRAMINE CITRATE	88637-37-0	DIPHENHYDRAMINE CITRATE
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
895664	ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral Tablet	PSN	fcfb044d-f6b9-5c43-e053-6394a90ac417	3
895664	diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral Tablet	SCD	fcfb044d-f6b9-5c43-e053-6394a90ac417	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
21130-228-12	21130022812	1 BOTTLE in 1 CARTON (21130-228-12) / 40 TABLET, COATED in 1 BOTTLE	1 bottle	2023-11-15	No	No	Current
21130-228-18	21130022818	1 BOTTLE in 1 CARTON (21130-228-18) / 80 TABLET, COATED in 1 BOTTLE	1 bottle	2023-11-15	No	No	Current
21130-228-23	21130022823	1 BOTTLE in 1 CARTON (21130-228-23) / 120 TABLET, COATED in 1 BOTTLE	1 bottle	2023-11-15	No	No	Current
21130-228-73	21130022873	1 BOTTLE in 1 CARTON (21130-228-73) / 20 TABLET, COATED in 1 BOTTLE	1 bottle	2023-11-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenhydramine Citrate and Ibuprofen Tablets USP 38 mg/200 mg	Better Living Brands, LLC \| Aurohealth LLC \| APL HEALTHCARE LIMITED	2024-10-29	Human OTC Drug Label	3